Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 4)

Description

On November 7, 2008, the Food and Drug Administration (FDA or we) published a final rule (Prior Notice rule) in the Federal Register, requiring submission to FDA of prior notice of food, including food for animals, that is imported or offered for import into the United States (73 FR 66294). The Prior Notice rule implements section 801(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(m)), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188) and requires that FDA receive prior notice of food imported into the United States. Section 304 of the FDA Food Safety Modernization Act (FSMA) (Public Law 111-353) amended section 801(m) of the FD&C Act.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

10

Imported Food

Food imported or offered for import into the United States; Articles of food imported or offered for import into the U.S.; Food products brought into the U.S.; food offered for import into the U.S.

Trade Sample

Food imported for commercial testing or display

Animal Food

Food intended for animal consumption subject to Part 507; Food for animal consumption manufactured, processed, packed, or held; Subject of the preventive controls regulation; Product manufactured by contract feed mills

Personal Baggage

Food carried by individuals for personal use

Household Goods

Food included in personal moves

Foreign Trade Zone

Status of food admitted into an FTZ

Egg products

Growth and survival of pathogens in egg products

Poultry products

Exempt from prior notice if under USDA jurisdiction

Meat food products

Exempt from prior notice if under USDA jurisdiction

Food for Animals

Includes food for animals that is imported

Stakeholders

10

Submitter

The entity providing information for the AFIC process.

carrier

individual or entity transporting the food

Ultimate Consignee

The party in the U.S. to whom the overseas shipper sold the merchandise

Consolidator

Firm that consolidates articles of food from different growers; Entity identified if grower identity is unknown

Grower

Identity required if known under FD&C Act; Identity of the person who grew the food article

Broker

Entity in the supply chain between the receiving facility and the supplier

Non-commercial shipper

Individual delivering food to a post office or common carrier

Transmitter

Entity transmitting the prior notice; Person who transmits prior notice information on behalf of a submitter; person or entity submitting the prior notice; Notification of prior notice refusals and holds will be provided to the transmitter.

Importers

persons affected by prior notice rules

Express carriers

Private delivery services like FedEx

Regulatory Context

Regulatory Activities

1

Prior Notice

Notification to FDA that an article of food is being imported; requirement for imported food products; Requirement for imported food under the FD&C Act; Requirement for food imported or offered for import into the U.S.; Requirement for articles of food imported or offered for import into the U.S.; Regulatory submission for imported food; submission of information for imported food; The rule requiring notification of imported food.

Document Types

1

CBP Broker Management Handbook

Reference document for customs brokers.

Attributes

4

Refusal Country

Name of any country to which the article has been refused entry

5 calendar days

The timeframe for submitting a request for review of a refusal or hold.

Estimated Quantity

Data element in prior notice that does not require resubmission if changed

Anticipated Time of Arrival

Local time at the anticipated port of arrival

Technical Details

Substances

5

Food contact substances

Materials that may migrate to raw materials or ingredients; address the safety of food contact substances in raw materials

Casings

Animal-derived containers for sausage under FDA jurisdiction

Meat

Subject to USDA or FDA depending on use

Pesticides

Regulated chemical residues in food; Ingredient-related chemical hazards; Chemical hazard managed via supply-chain controls.; Chemical hazard identified in oils, spices, and honey

Food additives

subject to prior notice requirements

Processes

2

Analytical Testing

Testing for contaminants like pesticides or heavy metals

International Mail

Method of shipping food requiring prior notice through PNSI

Identified Hazards

Hazards

1

Microbiological Contamination

Environmental factors affecting biological products

Standards & References

External Standards

5

Vienna Convention on Diplomatic Relations

Exemption for diplomatic bags

Public Law 107-188

Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

Public Law 111-353

FDA Food Safety Modernization Act (FSMA)

Federal Meat Inspection Act

USDA jurisdiction standard

Poultry Products Inspection Act

USDA jurisdiction standard

Related CFR Sections (9)

21CFR1.276§ 1.276 What definitions apply to this subpart?
(a) The act means the Federal Food, Drug, and Cosmetic Act.Read full regulation →
21CFR1.285§ 1.285 What happens to food that is imported or offered for import from unregistered facilities that are required to register under subpart H of this part ?
(a) Consequences. If an article of food from a foreign facility that is not registered as required under section 415 of the act ( 21 U.S.C. 350d ) and subpart H of this part is imported or offered for import into the United States, the food is subject to being held under section 801(l) of the act ( Read full regulation →
21CFR1.283§ 1.283 What happens to food that is imported or offered for import without adequate prior notice?
(a) For each article of food that is imported or offered for import into the United States, except for food arriving by international mail or food carried by or otherwise accompanying an individual, the consequences are:Read full regulation →
21CFR1.282§ 1.282 What must you do if information changes after you have received confirmation of a prior notice from FDA?
(a)Read full regulation →
21CFR1.281§ 1.281 What information must be in a prior notice?
(a) General. For each article of food that is imported or offered for import into the United States, except by international mail, you must submit the information for the article that is required in paragraphs (a)(1) through (18) of this section:Read full regulation →
21CFR1.280§ 1.280 How must you submit prior notice?
(a) You must submit the prior notice electronically to FDA. You must submit all prior notice information in the English language, except that an individual's name, the name of a company, and the name of a street may be submitted in a foreign language. All information, including the items listed in tRead full regulation →
21CFR1.279§ 1.279 When must prior notice be submitted to FDA?
(a) Except as provided in paragraph (c) of this section, you must submit the prior notice to FDA and the prior notice submission must be confirmed by FDA for review as follows:Read full regulation →
21CFR1.278§ 1.278 Who is authorized to submit prior notice?
A prior notice for an article of food may be submitted by any person with knowledge of the required information. This person is the submitter. The submitter also may use another person to transmit the required information on his/her behalf. The person who transmits the information is the transmitterRead full regulation →
21CFR1.277§ 1.277 What is the scope of this subpart?
(a) This subpart applies to all food for humans and other animals that is imported or offered for import into the United States for use, storage, or distribution in the United States, including food for gifts and trade and quality assurance/quality control samples, food for transshipment through theRead full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Did not develop, maintain, and follow an FSVP

3

Failure to develop, maintain, and follow an FSVP

3

Failure to develop an FSVP

2

Adulterated acidified chai teas

1

Failure to document evaluation of supplier performance

1

Failure to provide scheduled process information

1

Failure to conduct a written hazard analysis

1

Failure to have trained operating supervision

1

Failure to exercise sufficient pH control

1

Did not develop an FSVP for any of the foods you import

1